1.0 OBJECTIVE
1.1 The objective of this SOP is to define the procedure for line clearance from QA before commencement of new or further processing steps.
2.0 SCOPE
2.1 This SOP is applicable for line clearance from QA before commencement of new or further processing steps
3.0 RESPONSIBILITY
3.1 Officer / Executive – Quality Assurance
4.0 ACCOUNTABILITY
4.1 Head – Production / Quality Assurance
5.0 REFERENCE(S)
5.1 In-House
6.0 PROCEDURE
Before commencement of any processing related with dispensing, manufacturing as well as packing operation concerned department personnel will take line clearance from QA. As it is necessary to assure the inbuilt quality of product as per relevant standard and avoid any kinds of mix up or contamination. Detailed procedure of line clearance has been mentioned below:
6.1 After request from stores department or production department , QA personnel will go to the respective area and will check for Following before starting dispensing process :
6.1.1 Check and ensure that area is cleaned and cleaning records are maintained in the specified format.
6.1.2 Check and ensure that temperature and relative humidity of the area is within limit and it is recorded routinely on respective displayed format.
6.1.3 Check and ensure that RLAF pressure differential is showing pressure differential between the limit.
6.1.4 Check and ensure that dispensing equipment and accessories are cleaned and dry (wherever & whatever is applicable).
6.1.5 Check and ensure that weighing balances being used are cleaned and calibrated.
6.1.6 Visually check and ensure that dispensing area is free from previously dispensed material’s contamination
6.1.7 Check and ensure that personnel in side the dispensing area are having proper gowning and protective clothing (wherever and whatever is applicable).
6.1.8 After satisfactory inspection for all the above mentioned points Q.A. Personnel will give Line Clearance for starting further activities in respective Department by signing at respective column in line clearance format.
6.2 If request has been raised from production department related with line clearance for further processing in manufacturing area.
6.2.1 Check and ensure that area is clean and cleaning details of the same has been recorded in displayed respective “cleaning record”.
6.2.2 Check and ensure that temperature & humidity of the area is within limit and it is recorded routinely on respective displayed format.
6.2.3 Check and ensure that the return risers are clean.
6.2.4 Check and ensure that weighing balances being used are cleaned and calibrated.
6.2.5 Check and ensure that accessories are clean, dry and sanitized (wherever & whatever is applicable).
6.2.6 Check and ensure that equipment is clean and sanitized and it is having status label “Cleaned” and Wash Water Analysis Test report is available.
6.2.7 Check and ensure that no materials of previous products or batches are remaining inside the production area.
6.2.8 Check and ensure that personnel in side the respective area are maintaining adequate level of personnel hygiene.
6.2.9 Check and ensure that purified water / water for injection supplied inside the area is as per our acceptance criteria and the report of the same is available. .
6.2.10 After satisfactory inspection of all the above mentioned points QA personnel will give line clearance for starting further activities in respective department by signing at respective column in line clearance format / Batch Manufacturing Record.
6.3 If request has been raised from production department related with Line Clearance for further packing operation in packing Area. :
6.3.1 Check and ensure that area is clean and cleaning details of the same has been recorded in displayed respective “cleaning record”.
6.3.2 Check and ensure that temperature & humidity of the area is within limit and it is recorded routinely on respective displayed format.
6.3.3 Check and ensure that accessories being used are clean, dry & sanitized.
6.3.4 Check and ensure that weighing balances being used are cleaned and calibrated.
6.3.5 Check and ensure that personnel inside the packing area is having required protective clothing.
6.3.6 Check and ensure that equipment is clean, dry and it is having status Label “Cleaned”.
6.3.7 Check and ensure that remaining empty cartons, shippers and partition etc. of previous products or Batches have been removed from the packing area.
6.3.8 Check and ensure that on-line rejected filled or empty Containers, Cartons, Shippers and partition have been removed from the Packing area.
6.3.9 Check and ensure that Packed Shippers of Previous Products or Batches have been removed from the packing area.
6.3.10 Check and ensure that Personnel in side the respective area is maintaining adequate level of Personnel Hygiene.
6.3.11 After satisfactory inspecting all the above mentioned points QA Personnel will give Line Clearance for starting further activities in respective Department by signing at respective column in Line Clearance format.
7.0 ABBREVIATIONS
SOP : Standard Operating Procedure
QA : Quality Assurance
RLAF : Reverse Laminar Air Flow
IPQA : In process Quality Assurance
RH : Relative Humidity
BMR : Batch Manufacturing Record
BPR : Batch Packing Record